Pack of TEN: Best Selling Medical Devices Webinars by
Design History File (DHF), Device Master Record
(DMR), Device History Record (DHR) and Technical File
(TF) - Regulatory Documents Explained
The FDA QSR and the Medical Device Directive specify certain
documents or records that should be included in your organization's
quality systems - Design History File (DHF), the Device Master
Record (DMR) the Device History Record (DHR), and the Technical
Director of Regulatory
Affairs, Life-Tech, Inc
DHF, DMR, DHR, Technical File and Design Dossier -
Jeff Kasoff, RAC, is the Director of
Key Requirements and Future Directions
Quality at Byrne Medical, a leading
This webinar will examine the existing and proposed requirements
manufacturer of endoscopy
for the FDA's DHF - including its derivative documents, the DMR and
John E Lincoln
Interfacing Design Verification, Process Validation and
Consultant, Medical device
and Regulatory affairs
There is confusion between the requirements for Design
John E. Lincoln is a medical device
Verification, Process Validation and Design Validation.
and regulatory affairs consultant. He
has helped companies to implement
Device Changes and the 510(k)
or modify their GMP systems and
The majority of medical devices are cleared for marketing in the U.S.
by the FDA under the 510(k) process.
Edwin L Bills
FDA's New Enforcement of 21 CFR Part 11
Principal Consultant, Bilanx
FDA's new Part 11 regulation takes quite some time, but inspectors
go out and inspect computer systems and e-records for compliance
with GMPs and most recent Part11 interpretations.
During his 20 year career in medical
devices, Mr. Bills has held a number
of quality and regulatory affairs
The 510(k) Submission: Requirements, Contents, and
This presentation will provide an understanding of how to get a
Dr. Ludwig Huber
device requiring a 510(k) submission to market quickly.
Chief Advisor - Global FDA
The New FDA-Product Approval, Inspection, and
The US Food and Drug Administration has recently released
Ludwig Huber, Ph.D., is Director of
information about its new strategies as a result of the new
Labcompliance and Chief Advisor for
global FDA compliance at Agilent
Product Risk Management - ISO 14971:2007
This webinar will address the use of the ISO 14971 model to
Regulatory Affairs Specialist,
perform and document such activities and the additional actions
necessary to make it a useful product reference and training tool.
Albert Cefalo, Regulatory Affairs
Design History Files: Their Content and Control
Specialist, Analogic Corporation.
After attending this presentation the attendee should come away
Chuck has a BS degree from
with a good knowledge of what the requirements for Design History
Franklin Pierce College and a
Graduate certificate in RA from
Files are from both a domestic and international perspective, how
to minimize DHF content so that the requirements are still.
Complaint Handling in Compliance with FDA and ISO
Your Necessity is our Priority
This session will include the requirements for defining, documenting,
and implementing a complaint-handling system, including the
requirements for complaint review, investigation, and corrective
action, as well as the ISO-specific implications.
Click here to buy the webinar pack
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benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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